‘Point-of-Care’ Clinical Research Scalability Requires Interoperability

Leveraging interoperability standards may provide a more flexible framework for the scalability of “point-of-care” clinical research, according to a Health Affairs article.

A point-of-care trial is an operational approach to conducting clinical research that aims to make clinical trials accessible to more diverse populations by incorporating clinical trial processes into routine care delivery.

A common feature of successful point-of-care trials is integration with EHRs for multiple aspects of trial conduct, such as enrollment, randomization, and data collection. This integration may require modification of existing EHR systems that are typically not optimized for use in clinical trials.

Successful point-of-care trials also integrate research and clinical care delivery workflows.

“Generally, this means that patients receive their care without additional follow-up visits other than routine appointments,” the Health Affairs authors wrote. “In addition, research and care workflows are integrated to reduce burden on busy providers.”

The article noted that stakeholders must address limitations to the point-of-care trial approach before implementation.

“Clinician burden and regulatory challenges impact the feasibility of point-of-care trials,” they wrote. “Also, trial participant randomization and admission of clinical equipoise or treatment uncertainty could negatively affect the clinician-patient relationship.”

The authors recommended the following strategies for improving the point-of-care approach:

• Supplement EHR data with other sources.
• Leverage existing interoperability standards.
• Use data surveillance systems and establish a minimum set of common data elements.
• Align incentives both internal and external to health systems.
• Adopt a risk-proportionate regulatory framework.
• Streamline eligibility criteria and the consenting process.

Supplementing EHR data with other data sources, like patient-reported outcomes data, may provide a more complete framework for data collection than EHR data alone.

Leveraging existing interoperability standards and centralized data surveillance systems may further improve the implementation of the approach, the authors suggested.

Additionally, changes to the legal-regulatory framework governing trials may improve clinicians’ experiences with launching new trials.

“New guidance from regulators and more information about pre-defined evidentiary standards can further elucidate rules surrounding trial conduct for investigators,” the authors said.

They added that incentive alignment across internal and external health system stakeholders will be necessary to implement the point-of-care approach.

“Further changes to the clinical trials landscape, such as upfront investments in trial infrastructure and a longer-term funding model that supports sustainable point-of-care research, will be necessary for widespread point-of-care trial adoption,” the authors pointed out.

Moreover, centralized resources, such as a national point-of-care trials network, could increase the sustainability and scale of point-of-care trials.

“Patient, clinician, and health system prioritization of research and working toward a learning healthcare system will be necessary to successfully scale point-of-care trials,” they said.